Outline

Context: A major issue of outcome research is to close the gap between efficacy from pivotal studies and effectiveness under life conditions. As shown in a worldwide study programme fondaparinux demonstrated a dramatic reduction (<50%) of venous thromboembolism compared to low molecular weight heparin (Enoxaparin) in 7.344 patients undergoing major orthopaedic and traumatic surgery without increasing clinical relevant bleedings [Ref.Â 1].

Aim of the study: The aim of the observational CHANGE study was to evaluate the management of prophylaxis of venous thromboembolism with fondaparinux under real life conditions.

Material and method: Observational study in 111 hospitals in Germany. Patients underwent major orthopaedic (hip and knee replacement) or traumatic surgery (hip or pelvic fracture). Complete data sets of 7.787 patients were used for evaluation.

Conclusion: The CHANGE study confirms the results of pivotal studies (efficacy) of fondaparinux in patients undergoing major orthopaedic and traumatic surgery under real life conditions (effectiveness).